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Title

Psoriasis Area and Severity Index Version EMA (PASI EMA)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

PASI EMA

QRS Permission StatusPublic Domain
TeamPsoriasis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-06-2129
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Revision History

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© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

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Known Issue(s)
  • Version 1 of the Psoriasis Area and Severity Index CDISC Controlled Terminology is scheduled for deprecation and an associated QRS supplement will not be released.
  • There is not general agreement between industry, regulators, and academia on a standard set of responses for the PASI. Therefore, CDISC has created separate terminology and supplements for multiple references with different sets of responses for the PASI. This supplement uses the EMA guidelines for Psoriasis as the standard for responses.


Revision History

DateVersion
2022-06-291.0 Draft

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Psoriasis Area and Severity Index Version EMA (PASI EMA) instrument.  Version EMA (PASI EMA) instrument. Note that Version 1 of the CDISC Controlled Terminology is scheduled for deprecation and an associated CDISC Version 1 instrument and SDTMIG QRS supplement were never released.

There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.

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The PASI EMA is a tool used to assess the severity of psoriasis. However, there is no standard set of responses for the PASI that is used throughout the industry. This supplement uses the EMA guidelines for Psoriasis as the standard for responses. The PASI EMA divides the body into 4 sections (i.e., head, trunk, upper extremities, lower extremities) and assesses symptom severity and the percentage of each area affected by psoriasis. The symptoms are rated on a 5-point scale and the area is rated on a 6-point scale. Subscores for each section of the body and a total score are also captured.

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